Yingchun Wu
About Yingchun Wu
Yingchun Wu serves as the Commercial Stability Lead at Kite Pharma, bringing extensive experience in quality compliance and tech transfer within the pharmaceutical industry. With a strong educational background in Molecular Biology and Microbiology, Wu has held various leadership roles at notable companies, including Baxter International Inc., Takeda, and Shire.
Work at Kite Pharma
Yingchun Wu currently serves as the Commercial Stability Lead at Kite Pharma, a position held since 2020. In this role, Wu is responsible for overseeing commercial stability processes, ensuring compliance with quality standards, and managing partnerships with Contract Manufacturing Organizations (CMOs). Wu's expertise in quality compliance and tech transfer plays a significant role in the company's operations in Santa Monica, California.
Previous Experience in the Pharmaceutical Industry
Prior to joining Kite Pharma, Yingchun Wu held several key positions in the pharmaceutical industry. Wu worked at Baxter International Inc. as Manager of Global Product Stability from 2007 to 2014, and later as Senior Quality Product Owner at Baxalta from 2014 to 2016. Wu also served as Associate Director at Shire from 2016 to 2019 and at Takeda from 2019 to 2020, focusing on product quality and partnership quality leadership.
Education and Expertise
Yingchun Wu has a strong educational background in biological sciences. Wu earned a Doctor of Philosophy (PhD) in Microbiology from the University of Nevada-Las Vegas and a Master's degree in Molecular Biology from Jinan University, Center for Reproductive Immunology. Additionally, Wu studied Biology at Jiangxi University. This academic foundation supports Wu's expertise in quality compliance, tech transfer, and analytical method development.
Quality Compliance and Regulatory Knowledge
Yingchun Wu possesses hands-on knowledge in managing quality compliance with multiple international regulatory bodies, including the FDA, EMEA, MHRA, and CFDA. Wu's experience includes conducting non-conformance investigations and implementing corrective and preventive actions (CAPA) to maintain product quality. This expertise is crucial for ensuring that products meet stringent regulatory standards throughout their lifecycle.
Supplier Audits and External Collaborations
In addition to quality compliance, Yingchun Wu has experience in conducting supplier audits to ensure that external partners meet established quality standards. Wu manages partnerships and collaborations with Contract Manufacturing Organizations (CMOs), playing a key role in maintaining product quality and compliance across the supply chain. This experience is essential for fostering reliable relationships in the pharmaceutical industry.